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  5. Label Information: Loratadine

FDA Label for Loratadine

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK DOCTOR IF
    8. PREGNANCY/BREASTFEEDING
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. HOW SUPPLIED
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loratadine Product Label

The following document was submitted to the FDA by the labeler of this product Bryant Ranch Prepack. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient(S)



Active ingredient (in each tablet)
Loratadine USP, 10 mg



Purpose



Antihistamine


Use(S)



temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

Do Not Use



if you have ever had an allergic reaction to this product or any of its ingredients.



Ask A Doctor Before Use If You Have




liver or kidney disease. Your doctor should determine if you need a different dose.


When Using This Product



do not take more than directed. Taking more than directed may cause drowsiness.


Stop Use And Ask Doctor If



an allergic reaction to this product occurs. Seek medical help right away.


Pregnancy/Breastfeeding




ask a health professional before use.


Keep Out Of Reach Of Children



In case of overdose, get medical help or contact a Poison Control Center right away.


Directions





adults and children 6 years and over
1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor



Other Information



Bottles:

  • Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
  • store between 20° to 25°C (68° to 77°F)

    • Blisters packs:

    • safety sealed: do not use if the individual blister unit imprinted with loratadine is open or torn
    • store between 20° to 25°C (68° to 77°F)
    • protect from excessive moisture

Inactive Ingredients




corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch


Questions Or Comments?



Call 1-888-588-1418


How Supplied



Loratadine 10mg Tablet

  • NDC 71335-2391-1: 20 Tablets in a BOTTLE
  • NDC 71335-2391-2: 30 Tablets in a BOTTLE
  • NDC 71335-2391-3: 60 Tablets in a BOTTLE
  • NDC 71335-2391-4: 14 Tablets in a BOTTLE
  • NDC 71335-2391-5: 10 Tablets in a BOTTLE
  • NDC 71335-2391-6: 90 Tablets in a BOTTLE
  • NDC 71335-2391-7: 28 Tablets in a BOTTLE
  • NDC 71335-2391-8: 15 Tablets in a BOTTLE
  • NDC 71335-2391-9: 100 Tablets in a BOTTLE

    • Repackaged/Relabeled by:
    Bryant Ranch Prepack, Inc.
    Burbank, CA 91504


Package Label.Principal Display Panel



Loratadine 10mg Tablet

Label - lbl713352391

Label - lbl713352391


* Please review the disclaimer below.